Nuvaxovid JN.1
Italy
Table of Contents
Package leaflet: Information for the user
Nuvaxovid JN.1 dispersion for injectable suspension
COVID-19 vaccine (recombinant, adjuvanted)
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while receiving this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before receiving this vaccine as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet
- What Nuvaxovid JN.1 is and what it is used for
- What you need to know before receiving Nuvaxovid JN.1
- How Nuvaxovid JN.1 is administered
- Possible side effects
- How to store Nuvaxovid JN.1
- Contents of the pack and other information
1. What Nuvaxovid JN.1 is and what it is used for
Nuvaxovid JN.1 is a vaccine used to prevent COVID-19, a disease caused by the
SARS-CoV-2 virus.
Nuvaxovid JN.1 is administered to individuals aged 12 years and older.
The vaccine prompts the immune system (the body's natural defenses) to produce antibodies and
specialized white blood cells to fight the virus, thereby providing protection against COVID-19.
None of the components of this vaccine can cause COVID-19.
2. What you need to know before receiving Nuvaxovid JN.1
Do not receive Nuvaxovid JN.1
- if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving Nuvaxovid JN.1:
- if you have previously had a severe allergic reaction or a life-threatening reaction after receiving any injectable vaccine or after being administered Nuvaxovid or Nuvaxovid JN.1 in the past;
- if you have fainted after any needle injection;
- if you have a high fever (above 38 °C) or a serious infection. However, if you have a mild fever or a respiratory tract infection resembling a cold, you may still receive the vaccination;
- if you have bleeding disorders, are prone to bruising easily, or are taking a medicine to prevent blood clots;
- if your immune system is not functioning properly (immunodeficiency) or if you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants, or anticancer medicines).
An increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) has been observed after vaccination with Nuvaxovid; see section 4.
These conditions may develop within a few days of vaccination and have mainly occurred within 14 days.
After vaccination, you should be alert for signs of myocarditis and pericarditis, such as shortness of breath, palpitations, and chest pain, and if these occur, you should seek immediate medical attention.
If you fall under any of the above conditions (or have any doubts about them), consult your doctor, pharmacist, or nurse before receiving Nuvaxovid JN.1.
As with any vaccine, a single dose of Nuvaxovid JN.1 may not fully protect everyone who receives it, and the duration of protection is not known.
Children
Nuvaxovid JN.1 is not recommended for children and adolescents under 12 years of age. Currently, there is no information available on the use of Nuvaxovid JN.1 in children and adolescents under 12 years of age.
Other medicines and Nuvaxovid JN.1
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines or vaccines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor, pharmacist, or nurse for advice before receiving this vaccine.
Driving and using machines
Some of the side effects of Nuvaxovid JN.1 listed in section 4 (Possible side effects) could temporarily reduce your ability to drive vehicles or operate machinery (for example, feeling faint or dizzy, or feeling extremely tired).
Avoid driving or operating machinery if you do not feel well after vaccination. Before driving or using machinery, wait until any vaccine-related effects have passed.
Nuvaxovid JN.1 contains sodium and potassium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.
This medicine contains less than 1 mmol of potassium (39 milligrams) per dose, i.e., essentially “potassium-free”.
3. How Nuvaxovid JN.1 is administered
Individuals aged 12 years and older
Nuvaxovid JN.1 will be administered as a single 0.5 mL injection.
If you have previously received a COVID-19 vaccine, Nuvaxovid JN.1 should be administered
at least 3 months after the most recent dose of a COVID-19 vaccine.
The doctor, pharmacist, or nurse will inject the vaccine into a muscle, usually in the upper arm.
During and after each vaccine injection, the doctor, pharmacist, or nurse will observe you for
approximately 15 minutes to monitor for any signs of an allergic reaction.
Additional doses (0.5 mL) of Nuvaxovid JN.1 may be administered at the physician's discretion,
taking into account clinical conditions in accordance with national recommendations.
Immunocompromised individuals
If your immune system is not functioning properly, additional doses may be administered in
accordance with national recommendations.
4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everyone experiences them. Most side effects disappear within a few days of onset. If symptoms persist, consult your doctor, pharmacist, or nurse.
As with other vaccines, you may experience pain or discomfort at the injection site or notice redness and swelling at the site. However, these reactions usually resolve within a few days.
Seek urgent medical attention if you experience any of the following signs or symptoms of an allergic reaction:
- feeling faint or dizzy
- changes in heart rate
- shortness of breath
- wheezing
- swelling of the lips, face, or throat
- hives or skin rash
- nausea or vomiting
- stomach pain
Contact your doctor or nurse if any other side effect occurs. These may include:
Very common (may affect more than 1 in 10 people):
headache
nausea or vomiting
muscle pain
joint pain
pain or tenderness at the injection site
feeling extremely tired (fatigue)
general malaise
Common (may affect up to 1 in 10 people):
redness at the injection site
swelling at the injection site
fever (>38 °C)
pain or discomfort in the arm, hand, leg, and/or foot (limb pain)
Uncommon (may affect up to 1 in 100 people):
swollen lymph nodes
hypertension
itchy skin, skin rash, or hives
redness of the skin
itching at the injection site
chills
Rare (may affect up to 1 in 1,000 people):
warmth at the injection site
Not known (frequency cannot be estimated from available data):
- severe allergic reaction
- unusual skin sensations such as tingling or pricking (paresthesia)
- reduced sensation, especially of the skin (hypoesthesia)
- inflammation of the heart muscle (myocarditis) or inflammation of the outer lining of the heart (pericarditis), which may cause shortness of breath, palpitations, or chest pain
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system referred to in Annex V, including the batch number if available. Reporting side effects can help provide more information on the safety of this vaccine.
5. How to store Nuvaxovid JN.1
Keep this medicine out of the sight and reach of children.
The doctor, pharmacist, or nurse is responsible for the storage of this vaccine and for the proper disposal of any unused product.
Information on storage, expiry, use, and handling is provided in the section for healthcare professionals at the end of this leaflet.
6. Package contents and other information
What Nuvaxovid JN.1 contains
One dose (0.5 mL) of Nuvaxovid JN.1 contains 5 micrograms of spike protein* of
SARS-CoV-2 (Omicron JN.1) with Matrix-M adjuvant.
*Produced using recombinant DNA technology with a baculovirus expression system in an insect cell line derived from Sf9 cells of the species Spodoptera frugiperda.
- Matrix-M is included in this vaccine as an adjuvant. Adjuvants are substances contained in some vaccines to accelerate, enhance, and/or prolong the protective effects of the vaccine. The Matrix-M adjuvant contains fraction A (42.5 micrograms) and fraction C (7.5 micrograms) of extract from Quillaja saponaria Molina per 0.5 mL dose.
- The other components (excipients) contained in Nuvaxovid JN.1 are: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dihydrate, sodium chloride, polysorbate 80,
cholesterol,
phosphatidylcholine (including α-tocopherol, all-racemic),
potassium dihydrogen phosphate,
potassium chloride,
sodium hydroxide (for pH adjustment),
hydrochloric acid (for pH adjustment),
water for injections.
Description of the appearance of Nuvaxovid JN.1 and package contents
- A dispersion ranging from colourless to slightly yellow, from clear to slightly opalescent (pH 7.2).
- 0.5 mL of injectable dispersion in a vial with a rubber stopper and a blue plastic flip-off cap.
- Packaging: 1 single-dose vial or 10 single-dose vials. Each vial contains one 0.5 mL dose.
Marketing Authorisation Holder
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France
Manufacturer
Novavax CZ a.s.
Líbalova 2348/1, Chodov
149 00 Praha 4
Czech Republic
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Sanofi Belgium Swixx Biopharma UAB
tel: +32 2 710.54.00 Tel: +370 5 236 9140
България Luxembourg/Luxemburg
Swixx Biopharma EOOD Sanofi Belgium
Teл.: +359 2 4942 480 tel.: +32 2 710.54.00
Česká republika Magyarország
Sanofi s.r.o. SANOFI-AVENTIS Zrt
Tel: +420 233 086 111 Tel: +36 1 505 0055
Danmark Malta
Sanofi A/S Sanofi S.r.l.
Tel: +45 4516 7000 Tel: +39 02 39394 275
Deutschland Nederland
Sanofi-Aventis Deutschland GmbH Sanofi B.V.
Tel: 0800 54 54 010 Tel: +31 20 245 4000
Tel. aus dem Ausland: +49 69 305 21 130
Eesti Norge
Swixx Biopharma OÜ Sanofi-aventis Norge AS
Tel: +372 640 10 30 Tel: +47 67 10 71 00
Ελλάδα Österreich
ΒΙΑΝΕΞ Α.Ε. Sanofi-Aventis GmbH
Τηλ: +30.210.8009111 Tel: +43 (1) 80185-0.
España Polska
sanofi-aventis, S.A. Sanofi Sp. z o.o.
Tel: +34 93 485 94 00 Tel: +48 22 280 00 00
France Portugal
Sanofi Winthrop Industrie Sanofi – Produtos Farmacêuticos, Lda.
Tél: 0 800 222 555 Tel: +351 21 35 89 400
Appel depuis l’étranger : +33 1 57 63 23 23
Hrvatska România
Swixx Biopharma d.o.o Sanofi Romania SRL
Tel: +385 1 2078 500 Tel: +40 21 317 31 36
Ireland Slovenija
sanofi-aventis Ireland T/A SANOFI Swixx Biopharma d.o.o.
Tel: +353 (0) 1 4035 600 Tel: +386 1 2355 100
Ísland Slovenská republika
Vistor Swixx Biopharma s.r.o.
Tel: +354 535 7000 Tel: +421 2 20833 600
Italia Suomi/Finland
Sanofi S.r.l. Sanofi Oy
Tel: 800536389 Tel: +358 (0) 201 200 300
Κύπρος Sverige
C.A. Papaellinas Ltd. Sanofi AB
Τηλ.: +357 22 741741 Tel: +46 8-634 50 00
Latvija
Swixx Biopharma SIA
Tel: +371 6 6164 750
Scan the code with a mobile device to access the package leaflet in different languages.
Or visit the website: https://www.NovavaxCovidVaccine.com
Further sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.
The following information is intended exclusively for healthcare professionals:
Administer Nuvaxovid JN.1 by intramuscular injection, preferably into the deltoid muscle of the
arm, as a single dose.
In individuals previously vaccinated with a COVID-19 vaccine,
Nuvaxovid JN.1 should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Additional doses may be administered to severely immunocompromised individuals in
accordance with national recommendations.
Traceability
To improve the traceability of biological medicinal products, the name and batch number of the
administered product must be clearly recorded.
Instructions for handling and administration
Do not use this vaccine after the expiry date stated on the label and the carton following
Exp/EXP. The expiry date refers to the last day of that month.
This vaccine must be handled by a healthcare professional using aseptic techniques to ensure
the sterility of each dose.
Preparation for use
- The vaccine is supplied ready for use.
- The closed vial must be stored refrigerated (2 °C - 8 °C) and kept in the outer packaging to protect it from light.
- Immediately before use, remove the vaccine vial from the refrigerated carton.
- Discard the vial and any remaining volume after withdrawal and administration of one dose.
Vial inspection
- Gently rotate the vial before withdrawing the dose. Do not shake.
- Each vial contains a dispersion that ranges from colourless to slightly yellow and from clear to slightly opalescent.
- Before administration, visually inspect the vial contents for the presence of visible particulate matter and/or discoloration. If either condition is present, do not administer the vaccine.
Vaccine administration
- Each vial contains an overfill to ensure withdrawal of a 0.5 mL dose from the single-dose vial.
- A 0.5 mL dose is withdrawn into a sterile syringe using a sterile needle for intramuscular injection, preferably into the deltoid muscle of the arm.
- The vaccine must not be mixed in the same syringe with other vaccines or medicinal products.
Disposal
- Discard the vial and any remaining volume after withdrawal and administration of one dose.
Waste disposal
- Unused medicine and waste materials derived from this medicine must be disposed of in accordance with local regulations.
Package leaflet: Information for the user
Nuvaxovid JN.1 dispersion for injectable suspension in pre-filled syringe
Recombinant adjuvanted COVID-19 vaccine
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while receiving this medicinal product. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before receiving this vaccine as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet
- What Nuvaxovid JN.1 is and what it is used for
- What you need to know before receiving Nuvaxovid JN.1
- How Nuvaxovid JN.1 is administered
- Possible side effects
- How to store Nuvaxovid JN.1
- Package contents and other information
1. What Nuvaxovid JN.1 is and what it is used for
Nuvaxovid JN.1 is a vaccine used to prevent COVID-19, a disease caused by the
SARS-CoV-2 virus.
Nuvaxovid JN.1 is administered to individuals aged 12 years and older.
The vaccine prompts the immune system (the body's natural defenses) to produce antibodies and
specialized white blood cells to fight the virus, in order to provide protection against COVID-19.
None of the components of this vaccine can cause COVID-19.
2. What you should know before receiving Nuvaxovid JN.1
Nuvaxovid JN.1 must not be given to you
- if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving Nuvaxovid JN.1:
- if you have previously had a severe or life-threatening allergic reaction after receiving any other injectable vaccine or after being given Nuvaxovid or Nuvaxovid JN.1 in the past;
- if you have fainted after any needle injection;
- if you have a high fever (over 38 °C) or a serious infection. However, if you have a mild fever or a respiratory tract infection similar to a cold, you may still receive the vaccination;
- if you have bleeding problems, bruise easily, or are taking a medicine to prevent blood clots;
- if your immune system is not working properly (immunodeficiency) or if you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants, or anticancer medicines).
After vaccination with Nuvaxovid, there is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart), see section 4.
These conditions may occur within a few days of vaccination and have mainly occurred within 14 days.
After vaccination, you should be alert for signs of myocarditis and pericarditis, such as shortness of breath, palpitations, and chest pain, and if these occur, you should seek immediate medical attention.
If you have any of the conditions listed above (or have any doubts about them), talk to your doctor, pharmacist, or nurse before receiving Nuvaxovid JN.1.
As with any vaccine, a single dose of Nuvaxovid JN.1 may not fully protect all individuals who receive it, and the duration of protection is unknown.
Children
Nuvaxovid JN.1 is not recommended for children and adolescents under 12 years of age. Currently, there is no information available on the use of Nuvaxovid JN.1 in children and adolescents under 12 years of age.
Other medicines and Nuvaxovid JN.1
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines or vaccines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor, pharmacist, or nurse for advice before receiving this vaccine.
Driving and using machines
Some of the side effects of Nuvaxovid JN.1 listed in section 4 (Possible side effects) could temporarily reduce your ability to drive or operate machinery (for example, feeling faint or dizzy, or feeling extremely tired).
Avoid driving or operating machinery if you do not feel well after vaccination. Wait until any vaccine-related effects have passed before driving or using machinery.
Nuvaxovid JN.1 contains sodium and potassium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.
This medicine contains less than 1 mmol of potassium (39 milligrams) per dose, i.e., essentially “potassium-free”.
3. How Nuvaxovid JN.1 is administered
Individuals aged 12 years and older
Nuvaxovid JN.1 will be administered as a single 0.5 mL injection.
If you have previously received a COVID-19 vaccine, Nuvaxovid JN.1 should be administered
at least 3 months after the most recent dose of a COVID-19 vaccine.
The doctor, pharmacist, or nurse will inject the vaccine into a muscle, usually in the upper arm.
During and after each vaccine injection, the doctor, pharmacist, or nurse will observe you for
approximately 15 minutes to monitor for any signs of an allergic reaction.
Additional doses (0.5 mL) of Nuvaxovid JN.1 may be administered at the physician's discretion,
taking into account the clinical condition and in accordance with national recommendations.
Immunocompromised individuals
If your immune system is not functioning properly, additional doses may be administered in accordance with national recommendations.
4. Possible side effects
Like all medicines, this vaccine may cause side effects, although not everyone experiences them. Most side effects disappear within a few days of onset. If symptoms persist, consult your doctor, pharmacist or nurse.
As with other vaccines, you may experience pain or discomfort at the injection site, or observe redness and swelling at the site. However, these reactions usually resolve within a few days.
Seek urgent medical advice if you experience any of the following signs and symptoms of an allergic reaction:
- feeling faint or dizzy
- changes in heart rate
- shortness of breath
- wheezing
- swelling of the lips, face or throat
- hives or skin rash
- nausea or vomiting
- stomach pain
Consult your doctor or nurse if any other side effect occurs. These may include:
Very common (may affect more than 1 in 10 people):
headache
nausea or vomiting
muscle pain
joint pain
pain or tenderness at the injection site
feeling extremely tired (fatigue)
general feeling of being unwell
Common (may affect up to 1 in 10 people):
redness at the injection site
swelling at the injection site
fever (>38 °C)
pain or discomfort in the arm, hand, leg and/or foot (limb pain)
Uncommon (may affect up to 1 in 100 people):
enlarged lymph nodes
hypertension
itching of the skin, skin rash or hives
redness of the skin
itching at the injection site
chills
Rare (may affect up to 1 in 1,000 people):
warmth at the injection site
Not known (frequency cannot be estimated from the available data):
- severe allergic reaction
- unusual skin sensations such as tingling or pricking (paraesthesia)
- decreased sensation, especially of the skin (hypoesthesia)
- inflammation of the heart muscle (myocarditis) or inflammation of the outer lining of the heart (pericarditis), which may cause shortness of breath, palpitations or chest pain
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V, including the batch number if available. By reporting side effects, you can help provide more information on the safety of this vaccine.
5. How to store Nuvaxovid JN.1
Keep this medicine out of the sight and reach of children.
The doctor, pharmacist, or nurse is responsible for the storage of this vaccine and for the proper disposal of unused product.
Information on storage, expiry date, use, and handling are provided in the section for healthcare professionals at the end of this leaflet.
6. Package contents and other information
What Nuvaxovid JN.1 contains
One dose (0.5 mL) of Nuvaxovid JN.1 contains 5 micrograms of recombinant spike protein* of
SARS-CoV-2 (Omicron JN.1) with Matrix-M adjuvant.
*Produced using recombinant DNA technology with a baculovirus expression system in an insect cell line derived from Spodoptera frugiperda Sf9 cells.
- Matrix-M is included in this vaccine as an adjuvant. Adjuvants are substances contained in certain vaccines to accelerate, enhance, and/or prolong the protective effects of the vaccine. The Matrix-M adjuvant contains fraction A (42.5 micrograms) and fraction C (7.5 micrograms) of extract from Quillaja saponaria Molina per 0.5 mL dose.
- The other components (excipients) contained in Nuvaxovid JN.1 are:
disodium hydrogen phosphate heptahydrate
sodium dihydrogen phosphate monohydrate
disodium hydrogen phosphate dihydrate
sodium chloride
polysorbate 80
cholesterol
phosphatidylcholine (including all-rac-α-tocopherol)
potassium dihydrogen phosphate
potassium chloride
sodium hydroxide (for pH adjustment)
hydrochloric acid (for pH adjustment)
water for injections
Description of the appearance of Nuvaxovid JN.1 and contents of the package
- Colourless to slightly yellowish dispersion, clear to slightly opalescent (pH 7.2).
- 0.5 mL of injectable dispersion in a pre-filled syringe with plunger stopper and closure cap, without needle or co-packaged with a separate needle.
- Pack: either 10 pre-filled syringes, or 1 pre-filled syringe, or 1 pre-filled syringe with a separate needle.
- Each syringe contains 1 dose of 0.5 mL.
Marketing Authorisation Holder
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France
Manufacturer
Novavax CZ a.s.
Líbalova 2348/1, Chodov
149 00 Praha 4
Czech Republic
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Sanofi Belgium Swixx Biopharma UAB
tel: +32 2 710.54.00 Tel: +370 5 236 9140
България Luxembourg/Luxemburg
Swixx Biopharma EOOD Sanofi Belgium
Teл.: +359 2 4942 480 tel.: +32 2 710.54.00
Česká republika Magyarország
Sanofi s.r.o. SANOFI-AVENTIS Zrt
Tel: +420 233 086 111 Tel: +36 1 505 0055
Danmark Malta
Sanofi A/S Sanofi S.r.l.
Tel: +45 4516 7000 Tel: +39 02 39394 275
Deutschland Nederland
Sanofi-Aventis Deutschland GmbH Sanofi B.V.
Tel: 0800 54 54 010 Tel: +31 20 245 4000
Tel. from abroad: +49 69 305 21 130
Eesti Norge
Swixx Biopharma OÜ Sanofi-aventis Norge AS
Tel: +372 640 10 30 Tel: +47 67 10 71 00
Ελλάδα Österreich
ΒΙΑΝΕΞ Α.Ε. Sanofi-Aventis GmbH
Τηλ: +30.210.8009111 Tel: +43 (1) 80185-0.
España Polska
sanofi-aventis, S.A. Sanofi Sp. z o.o.
Tel: +34 93 485 94 00 Tel: +48 22 280 00 00
France Portugal
Sanofi Winthrop Industrie Sanofi – Produtos Farmacêuticos, Lda.
Tél: 0 800 222 555 Tel: +351 21 35 89 400
Call from abroad: +33 1 57 63 23 23
Hrvatska România
Swixx Biopharma d.o.o Sanofi Romania SRL
Tel: +385 1 2078 500 Tel: +40 21 317 31 36
Ireland Slovenija
sanofi-aventis Ireland T/A SANOFI Swixx Biopharma d.o.o.
Tel: +353 (0) 1 4035 600 Tel: +386 1 2355 100
Ísland Slovenská republika
Vistor Swixx Biopharma s.r.o.
Tel: +354 535 7000 Tel: +421 2 20833 600
Italia Suomi/Finland
Sanofi S.r.l. Sanofi Oy
Tel: 800536389 Tel: +358 (0) 201 200 300
Κύπρος Sverige
C.A. Papaellinas Ltd. Sanofi AB
Τηλ.: +357 22 741741 Tel: +46 8-634 50 00
Latvija
Swixx Biopharma SIA
Tel: +371 6 6164 750
Scan the code with a mobile device to access the package leaflet in multiple languages.
Or visit the website: https://www.NovavaxCovidVaccine.com
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.
The following information is intended exclusively for healthcare professionals:
Administer Nuvaxovid JN.1 by intramuscular injection, preferably into the deltoid muscle of the arm, as a single dose.
In individuals previously vaccinated with a COVID-19 vaccine, Nuvaxovid JN.1 should be administered at least 3 months after the most recent dose of any COVID-19 vaccine.
Additional doses may be administered to severely immunocompromised individuals in accordance with national recommendations.
Traceability
To improve the traceability of biological medicinal products, the name and batch number of the administered product must be clearly recorded.
Instructions for handling and administration
Do not use this vaccine after the expiry date stated on the label and carton following Scad/EXP. The expiry date refers to the last day of that month.
This vaccine must be handled by a healthcare professional using aseptic techniques to ensure sterility of each dose.
Preparation for use
- The vaccine is supplied ready for use.
- The prefilled syringe must be stored refrigerated (2 °C - 8 °C) and kept in its outer packaging to protect from light.
- Immediately before use, remove the prefilled syringe from the carton stored in the refrigerator.
- Each prefilled syringe is for single use only.
Inspection of the prefilled syringe
- Do not shake the prefilled syringe.
- Each prefilled syringe contains a dispersion that ranges from colourless to slightly yellow and from clear to slightly opalescent.
- Before administration, visually inspect the contents of the prefilled syringe for visible particulate matter and/or discoloration. Do not administer the vaccine if either condition is present.
- Do not use the prefilled syringe if the closure cap has been removed or is missing.
- Do not use the prefilled syringe if visible leaks or cracks are present.
Administration of the prefilled syringe
- Prefilled syringe without needle or Needles are not included in prefilled syringe cartons.
o Use a sterile needle of appropriate size for intramuscular injection (21 gauge or finer).
- Prefilled syringe with a separate needle or Use a needle included in the package.
- Holding the prefilled syringe with the closure cap facing upwards, remove it by rotating counterclockwise until it detaches. Remove the closure cap with a slow, continuous motion. Do not pull on the closure cap while rotating.
- Attach the needle by rotating it clockwise until firmly secured to the syringe.
- Remove the needle cap when ready for administration.
- Administer the entire dose intramuscularly, preferably into the deltoid muscle of the arm.
Disposal
- Discard the prefilled syringe after administration.
Waste disposal
- Unused medicine and waste materials derived from this medicine must be disposed of in accordance with local regulations.